Associate Principal Scientist, Preclinical Development

Role

Associate Principal Scientist supporting biologics sterile product development within the Sterile Product Development (SPD) group.

Objectives

Lead innovative biologics formulation and process development, support early and late-stage candidates, and contribute to regulatory filings.

Responsibilities

• Design and execute experiments for biologics drug products
• Oversee process scalability, primary packaging, and compatibility
• Lead technology transfers and external manufacturing collaborations
• Provide strategic and technical leadership on programs
• Mentor scientists and drive innovation aligned with organizational goals

Qualifications

Ph.D. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, or related field with at least 3 years (Ph.D.) or 8 years (B.S./M.S.) of industry experience in biologics process development.

Skills

Expertise in biologics formulation, characterization, process development, and regulatory submission; strong communication and leadership abilities.

Preferred

Experience leading enterprise-level projects, mentoring, subject matter expertise in drug delivery or manufacturing tech, and process scale-up knowledge.

High-Value

Biologics, sterile injectable drug products, late-stage development, process characterization, regulatory filings, external manufacturing, and innovation in drug delivery technologies.

Work Setup

Not specified; travel approximately 10%.